BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23490120 · Received November 6, 2025

    Report

    Report Number
    9617601-2025-02560
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FRAZZETTO ET AL. COMPARISON OF EVOLUT FX WITH LATEST-GENERATION EVOLUT FX+ TRANSCATHETER AORTIC VALVE SYSTEMS IN REAL-WORLD PRACTICE. JACC. OCTOBER 22, 2025. VOL. 86, NO. 17_SUPPLEMENT. DOI: 10.1016/J.JACC.2025.09.1055. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A COMPARISON OF EVOLUT FX WITH THE LATEST-GENERATION EVOLUT FX+ TRANSCATHETER AORTIC VALVE SYSTEMS. THE STUDY POPULATION INCLUDED 9,889 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 80 YEARS OLD. PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT FX (N= 7,353) OR AN EVOLUT FX+ (N= 2,536) BIOPROSTHETIC VALVE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE, MAJOR VASCULAR COMPLICATION, AND SECOND VALVE DURING IMPLANT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906031 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H| L